IGF1 Generation Test (CAREL)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00145457
First received: September 1, 2005
Last updated: June 5, 2007
Last verified: May 2007
  Purpose

To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.


Condition Intervention Phase
Growth Hormone Deficiency
Procedure: Blood sample
Procedure: Radiography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.

Estimated Enrollment: 82
Study Start Date: April 2001
Estimated Study Completion Date: January 2005
  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged of more than 4 years.
  • GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities

Exclusion Criteria:

  • Previous treatment with GH
  • Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145457

Locations
France
Pfizer Investigational Site
Besançon, France, 25030
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Dunkerque, France, 59385
Pfizer Investigational Site
Limoges Cedex, France, 87042
Pfizer Investigational Site
Nice, France, 06202
Pfizer Investigational Site
Paris Cedex 14, France, 75674
Pfizer Investigational Site
Tarbes, France, 65013
Pfizer Investigational Site
Toulouse Cedex 9, France, 31059
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145457     History of Changes
Other Study ID Numbers: 307-MET-9002-040, A6281023
Study First Received: September 1, 2005
Last Updated: June 5, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014